Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy (TREATGENE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996824
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Institut Pasteur

Tracking Information
First Submitted Date June 21, 2019
First Posted Date June 25, 2019
Last Update Posted Date July 16, 2019
Actual Study Start Date February 19, 2019
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2019)
AAV transduction in inner ear cells [ Time Frame: 10 days ]
The transduction will be measured with immunostaining techniques
Original Primary Outcome Measures
 (submitted: June 21, 2019)
AAV tranduction in inner ear cells [ Time Frame: 10 days ]
The transduction will be measured with immunostaining techniques
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
Official Title Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
Brief Summary

Gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and Associated adenovirus (AAV) is shown as a good viral vector for inner ear therapy in animal models.

This study aims to study in vitro viral transduction of AAV in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
inner ear cells collected during surgery
Sampling Method Non-Probability Sample
Study Population Patients undergoing surgical resection of vestibular schwannoma.
Condition Hearing Loss, Sensorineural
Intervention Other: Peroperative collect of inner ear cells

After obtaining an informed consent during the preoperative medical visit, and if a non-conservative approach (translabyrinthine or transotic) is decided, the collect of inner ear cells will be performed during surgical approach.

The sample will be collect in a sterile tube, and carried to the laboratory were it will be placed bon cell culture.

Study Groups/Cohorts AAV viral transduction
Collection of inner ear cells during a non-conservative surgical approach (translabyrinthine or transotic).
Intervention: Other: Peroperative collect of inner ear cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 21, 2019)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2022
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient ≥ 18 years old
  • Operative indication for a non-conservative resection of vestibular schwannoma, decided by the surgeon in accordance with the patient
  • Informed consent obtained
  • Patients with a french social protection (AME excluded)

Exclusion Criteria:

  • Intravestibular or intra-cochlear extension of the tumor
  • Pregnant woman
  • Patient with administrative control
  • Medical contra-indication
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ghizlene Lahlou 33 1 45688891 ghizlene.lahlou@pasteur.fr
Contact: Saaid Safieddine saaid.safieddine@pasteur.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03996824
Other Study ID Numbers 2017-081
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut Pasteur
Study Sponsor Institut Pasteur
Collaborators Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Ghizlene Lahlou Institut Pasteur
PRS Account Institut Pasteur
Verification Date July 2019